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Trial record 1 of 1 for:    Astellas 3772-CL-2001
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A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525599
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Affinivax, Inc.

Tracking Information
First Submitted Date  ICMJE August 21, 2020
First Posted Date  ICMJE August 25, 2020
Last Update Posted Date June 6, 2022
Actual Study Start Date  ICMJE September 22, 2020
Actual Primary Completion Date April 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 30 ]
    A TEAE is defined as an adverse event (AE) observed after study vaccination and up to 30 days post-vaccination. A vaccine-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
  • Number of Participants With Body Temperature Abnormalities and/or Adverse Events [ Time Frame: Up to Day 30 ]
    Number of participants with potentially clinically significant body temperature abnormalities.
  • Reactogenicity Assessed by Number of Solicited Local Reactions [ Time Frame: Up to Day 7 ]
    Local reactions are tenderness, movement restriction, redness/erythema and swelling and induration. Local reactogenicity will be evaluated at approximately 30 to 60 minutes post-dose by study site personnel and recorded in an electronic diary device by the participant's parent/legal guardian while at the study site on day 1. The participant's parent/legal guardian will observe reactogenicity and tolerability from day 2 through day 7, and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
  • Reactogenicity assessed by Number of Solicited Systemic Reactions [ Time Frame: Up to Day 7 ]
    Systemic reactions are vomiting, diarrhea, fever, irritability, decrease of appetite and increase or decrease in sleep. Body temperature will be assessed pre-dose and approximately 30 to 60 minutes post-dose. The participant's parent/legal guardian will be asked to observe the systemic reactogenicity symptoms from day 2 through day 7 and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • Proportion of Participants Achieving a Serotype-specific Anticapsular Polysaccharide Immunoglobulin G (PS IgG) Concentration of ≥ 0.35 µg/mL for ASP3772 [ Time Frame: Up to 30 days ]
    PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of ASP3772.
  • Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13 [ Time Frame: Up to 30 days ]
    PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of PCV13.
  • Proportion of Participants Achieving a Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer ≥ 1:8 for ASP3772 [ Time Frame: Up to 30 days ]
    OPA measure will be used to characterize the immunological response 30 days following administration of ASP3772.
  • Proportion of Participants Achieving a Serotype-specific OPA Antibody Titer ≥ 1:8 for PCV13 [ Time Frame: Up to 30 days ]
    OPA measure will be used to characterize the immunological response 30 days following administration of PCV13.
  • Geometric Mean Titer (GMT) for Serotype-specific OPA for ASP3772 [ Time Frame: Up to 30 days ]
    OPA measure will be used to characterize the immunological response 30 days following administration of ASP3772.
  • Geometric Mean Titer (GMT) for Serotype-specific OPA for PCV13 [ Time Frame: Up to 30 days ]
    OPA measure will be used to characterize the immunological response 30 days following administration of PCV13.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
Official Title  ICMJE A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
Brief Summary

The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13.

This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.

Detailed Description

After screening, participants will be randomized to ASP3772 or PCV13 on Day 1. A single dose of ASP3772 will be administered on Day 1 as an injection into the right or left thigh muscle at one of three dose levels. The participants randomized to PCV13 will receive a single intramuscular injection of the approved dose of PCV13 into the right or left thigh muscle. All participants will remain at the study site for approximately 30 to 60 minutes following vaccination in order for study site personnel to evaluate any immediate reactions, if needed. The participant's parent/legal guardian will observe for reactions, including daily body temperature measurements and tolerability assessments, from Day 2 through Day 7 and record observed events in the electronic diary device.

All participants will have study visits on Day 7 (+ 1 day) and Day 30 (± 5 days) post-vaccination. The Day 7 visit may be conducted on site or by telephone call.The end-of-study visit will occur on Day 180 (± 14 days), which will be a safety follow-up by telephone call.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy Volunteers
  • Pneumococcal Disease
Intervention  ICMJE
  • Biological: ASP3772
    Intramuscular (IM) injection
  • Biological: PCV13
    Intramuscular injection
    Other Name: Prevnar 13
Study Arms  ICMJE
  • Experimental: Group 1, ASP3772 Low Dose
    Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a low-dose level.
    Intervention: Biological: ASP3772
  • Active Comparator: Group 1, PCV13 Comparator
    Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
    Intervention: Biological: PCV13
  • Experimental: Group 2, ASP3772 Medium Dose
    Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a medium-dose level.
    Intervention: Biological: ASP3772
  • Active Comparator: Group 2, PCV13 Comparator
    Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
    Intervention: Biological: PCV13
  • Experimental: Group 3, ASP3772 High Dose
    Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a high-dose level.
    Intervention: Biological: ASP3772
  • Active Comparator: Group 3, PCV13 Comparator
    Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
    Intervention: Biological: PCV13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2020)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 6, 2022
Actual Primary Completion Date April 6, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a healthy toddler who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
  • Subject is afebrile within the last 48 hours (temperature measured orally is < 100 °F [37.8°C]; measured rectally or tympanic is < 101 °F [38.3°C]; measured in an axillary position or temporal is < 98.4 °F [36.9°C]).
  • Subject's parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
  • Subject's parent/legal guardian along with the subject is able and is willing to attend all scheduled visits and to comply with the study procedures.
  • Subject's parent/legal guardian has access to a telephone.
  • Subject's parent/legal guardian agrees not to enroll subject in another interventional study while participating in the present study.

Exclusion Criteria:

  • Subject has a known hypersensitivity to any vaccine.
  • Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs, known or suspected impairment of immunological function or a history of congenital or acquired immunodeficiency.
  • Subject has or his/her mother has known human immunodeficiency virus infection or known to be hepatitis B surface antigen-positive.
  • Subject has functional or anatomic asplenia.
  • Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
  • Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
  • Subject has any active malignancy or history of malignancy.
  • Subject has been in receipt of intramuscular, oral, intravenous, inhaled or intranasal corticosteroid treatment within 2 weeks prior to study vaccination or is planned to receive these medications within 4 weeks after study vaccination. Note: Use of topical corticosteroids is permitted.
  • Subject has received any live-attenuated vaccines within 4 weeks prior to receipt of the study vaccine or inactivated vaccines within 2 weeks prior to receipt of study vaccine.
  • Subject has previously received an approved (other than PCV13) or investigational pneumococcal vaccine.
  • Subject has had any prior receipt of a blood transfusion or blood products, including immunoglobulins.
  • Subject has received investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
  • Subject has received a systemically absorbed antibacterial agent within 7 days prior to study vaccination.
  • Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
  • Subject has received acetaminophen or nonsteroidal anti-inflammatorydrugs (NSAIDs) within 24 hours prior to receipt of study vaccine.
  • Subject has a coagulation disorder.
  • Subject's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study and the subject cannot be adequately followed for safety according to the protocol.
  • Subject who has a condition which makes the subject unsuitable for study participation.
  • Subject's parent(s)/legal guardian is an employee of Astellas Pharma Global Development Inc., the study-related contract research organizations (CROs), or the study site.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04525599
Other Study ID Numbers  ICMJE 3772-CL-2001
2019-004503-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Current Responsible Party Affinivax, Inc.
Original Responsible Party Astellas Pharma Global Development, Inc.
Current Study Sponsor  ICMJE Affinivax, Inc.
Original Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Global Development, Inc.
PRS Account Affinivax, Inc.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP